Reporting of registration holder pursuant to Section 33, paragraph 2 of Act on Pharmaceuticals

Information to fulfill legal obligations of marketing authorisation holders

The State Institute for Drug Control (hereinafter referred to as the “Institute”) wishes to draw the attention to the obligations set out in Act No 378/2007 Coll., on Pharmaceuticals and on Amendments to Some Related Acts (hereinafter referred to as the “Act on Pharmaceuticals”).  


The recommended procedures

The recommended procedures for submitting correct and complete reporting of marketing authorization holders on the volume of supplies of human medicinal products placed on the market in the Czech Republic (REG-13).